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Environmental Design for Behavioral Regulation in People With Dementia

NCT04555616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-12

Study results available
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Summary

Individuals with dementia present with changes in behaviors throughout the continuum of cognitive decline. Environmental features may be influential in behavioral regulation. The purpose of this study is to assess the feasibility of environmental design protocols in older adults with dementia and their caregivers. Thirty subjects with moderate to severe Alzheimer's disease as primary dementia type, and their caregivers, will be randomly assigned to one of three arms: standard care; standard environmental design protocol; or personalized environmental design protocol.

Conditions

  • Alzheimer Disease

Interventions

BEHAVIORAL

Standard Environmental Design

Participants' caregivers will receive set script of physical environmental modifications (i.e., declutter living space, reduce background noise, increase natural light), and social environment training script will include caregiving techniques: training for calming demeanor (emotional contagion), needs-driven care to decrease behavioral disruption, and accepting and accommodating approach to behavioral disruption. A pre-selected sensory stimulation kit will be provided to each participants' caregiver for administration throughout the day.

BEHAVIORAL

Individual Environmental Design

Participants' caregivers will receive set script of physical environmental modifications and social environment training script in a standard protocol. Following initial assessments, individualized sensory stimulation kits will be developed using subjects' preferred sensory stimuli (as determined by the Adult Sensory Profile assessment and informant report) and will be provided via caregiver administration throughout the day to promote maintained behavioral regulation.

BEHAVIORAL

Placebo

Participants' caregivers will receive a set script of placebo modifications.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Elizabeth K Rhodus

    lead OTHER

Principal Investigators

  • Gregory Jicha, MD-PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2021-10-13
Completion
2021-10-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04555616 on ClinicalTrials.gov